Tobacco Product Events (PI) Specification

Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.

Permissible rather than required because events may happen to or with a device that do not involved subjects, and may even be before the device was in contact with a subject. In these cases there may not be a value for USUBJID.

Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. 

Sequence Number given to ensure uniqueness of records.

Sponsor-defined reference number.

Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Note that it does not have to be numeric.

Verbatim name of the observed event.

Examples: "Screw Breakage", "Fissure Formation", "Battery Issue".

The modified text for DETERM.

If DETERM is modified, then the modified text is placed here.

Dictionary-derived form of the event described in DETERM.

Dictionary-derived text description of DETERM or DEMODIFY. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element.

Used to define a categorization level for events.

For example, "MALFUNCTION" vs. "CALIBRATION".

Used to define a further category level for events.

For example, "EXTERNAL" vs. "INTERNAL".

Used to indicate whether (Y/null) information about a specific event was solicited on the CRF.

For example, DETERM could contain a list of malfunctions that are being specifically evaluated. DEPRESP would identify those (Y), whereas any spontaneous events would have DEPREST null.

When information about specific events is solicited, DEOCCUR is used to indicate whether or not (Y/N) a particular pre-specified event occurred.

Values are null for events not specifically solicited.

The status indicates that the pre-specified question was not answered.

For example, if equipment operation requires checking, such as checking an event log to detect events. Capturing that the checks were not completed may be relevant to interpreting the study data.

Reason DESTAT was "NOT DONE".

This variable should only be used if there are pre-specified events.

Describes Action Taken with respect to the device.

Action Taken may include removal, calibration, reprogramming, and so on. Action is usually in response to some event, for example, a subject's adverse event.

Clinical encounter number.

Numeric version of VISIT, used for sorting.

Protocol-defined description of clinical encounter.

May be used in addition to VISITNUM and/or VISITDY.

Planned study day of the visit based upon RFSTDTC in Demographics.

This value is usually derived.

Date the device event information was collected.

This may be reported if the event (e.g., malfunction) is discovered on a different date from the event.

Start date/time of the device event.

If the event happened at a single point in time, DESTDTC is used.

End date/time of the device event.

If an event lasted over a period of time, DEENDTC can be used to capture the end date/time.

Study day of Device Event observation, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.

Study day of start of Device Event, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.

Study day of end of Device Event, measured as integer days.

Algorithm for calculations must be relative to the sponsor-defined RFENDTC variable in Demographics.